General Medication Disposable System

ABSTRACT

General medication disposal systems are provided. Aspects of the systems include devices having a sealable container dimensioned to accommodate a pharmaceutical composition; and an amount of an inactivating substance, e.g., granulated or pelletized activated carbon, present inside of the of sealable container. Aspects of the invention further include methods of making and using the systems, as well as kits comprises the devices of the system.

CROSS-REFERENCE TO RELATED APPLICATIONS

Pursuant to 35 U.S.C. §119 (e), this application claims priority to thefiling date of U.S. Provisional Patent Application Ser. No. 61/542,026filed on Sep. 30, 2011; the disclosure of which application is hereinincorporated by reference.

INTRODUCTION

The temptation and potential for prescription drug abuse by ingestion,injection, etc., and particularly, of narcotics and other controlledsubstances is well known. This widespread abuse issue is exemplified bythe current problems associated with morphine, oxycontin, fentanyl, andmany others.

Unfortunately, problems associated with medications are not limited toabusable narcotics. According to a recent investigative report by theAssociated

Press, Americans flush 250 million pounds of pharmaceuticals down thedrain every year (see e.g., Living on Earth.org online interview withthe EPA, Oct. 3, 2008). Furthermore, this practice of pharmaceuticalcomposition disposal has resulted in contamination of the drinking watersupply of numerous major cities throughout the U.S. (see e.g., Air ForcePrint News Today, Mar. 24, 2008).

These contaminants pose risk to the environment; affecting people, fishand wildlife. Potential problems include abnormal physiologicalprocesses, reproductive impairment, increased evidence of cancer, anddevelopment of anti-microbial resistant organisms (reference: KansasDept of Health and Environment, Mar. 22, 2007). A significant source ofpharmaceutical environmental contamination lies with disposal of unusedor expired medications (reference eMedicineHealth Mar. 21, 2008).Historically, these medications are flushed down the toilet or throwninto the trash, with a likely outcome that they will eventually end upin groundwater supplies. The only medications that the FDA condonesflushing down the toilet are controlled substances with abuse potential.Thus, many people are faced with a dilemma of how best to dispose ofunused and expired medications.

Of particular interest is the potential for abuse or environmentalrelease associated with medications contained in transdermal patchtechnology. Unfortunately, with transdermal patches significant amountsof drug compound remain in the patches after patients have worn them forthe prescribed period of time. The need for this excess amount of drugis well known; it is required to ensure an adequate driving force in thetransdermal application for the full wear time period. For example, in apublished test of Duragesic® (trademark of Johnson & Johnson) patchesworn for the full 72-hour wear period, 28-84.4% of the original loadingof fentanyl still remained in the patches. The authors of the studyconcluded that the residual dosage represented amounts sufficient forabuse and misuse and was even potentially lethal (Marquardt et al, AnnPharmacother, 1995, 29:969-71).

Environmental and abuse problems are certainly not limited tomedications in transdermal patch form. In fact, medications are mostoften in oral pill or liquid solution form. Once unused or expired oralmedications are discarded, these medications may be recovered from thetrash and abused by others. In addition, compounds from large amounts ofdiscarded medications are inevitably released to the ground water supplyover time.

SUMMARY

Medication disposal systems are provided. Aspects of the systems includedevices having a sealable container dimensioned to accommodate apharmaceutical composition; and an amount of an inactivating substance,e.g., granulated or pelletized activated carbon, present inside of theof sealable container. Aspects of the invention further include methodsof making and using the systems, as well as kits comprises the devicesof the system.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A provides a view of an embodiment pharmaceutical compositiondisposal device having an inner pouch that contains a waterpermeable/carbon impermeable separator barrier. FIG. 1B shows avariation of the device shown in FIG. 1A that includes a vent.

FIGS. 2A to 2G depict the sequence of how the device depicted in FIG. 1Amay be used to dispose of a pharmaceutical composition.

FIG. 3 provides experimental results with comparisons of deactivationbetween Untreated Control, Cat Litter, Coffee Grounds, GranularActivated Carbon (Design A, Free Carbon), and Granular Activated Carboncontained in an Inner Pouch (Design B, Carbon in Pouch).

DETAILED DESCRIPTION

Medication disposal systems are provided. Aspects of the systems includedevices having a sealable container dimensioned to accommodate apharmaceutical composition; and an amount of an inactivating substance,e.g., granulated or pelletized activated carbon, present inside of theof sealable container. Aspects of the invention further include methodsof making and using the systems, as well as kits comprises the devicesof the system.

Before the present invention is described in greater detail, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Certain ranges are presented herein with numerical values being precededby the term “about.” The term “about” is used herein to provide literalsupport for the exact number that it precedes, as well as a number thatis near to or approximately the number that the term precedes. Indetermining whether a number is near to or approximately a specificallyrecited number, the near or approximating unrecited number may be anumber which, in the context in which it is presented, provides thesubstantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

In further describing various embodiments of the invention, aspects ofthe devices are reviewed first in greater detail, followed by a detaileddescription of embodiments of using the devices and a review of kitsthat include the devices.

Devices

As summarized above, devices for use in disposal of pharmaceuticalcompositions are provided. Aspects of the devices include a sealablecontainer and an amount of an inactivating agent present in thecontainer. The sealable container may have any convenient configuration.In some instances, the sealable container is dimensioned to accommodatea pharmaceutical composition that is to be inactivated. Configurationsof interest for the container include, but are not limited to, bottles,bags, pouches, etc., where the walls of the container may be rigid orflexible, as desired. In those embodiments where the containers aredimensioned to accommodate a pharmaceutical composition, the interiorvolume of the container will be such that the pharmaceutical compositioncan be positioned inside of the container, where in some instances whenthe pharmaceutical composition is placed inside of there is alsoadditional space to accommodate a volume of liquid, e.g., from ¼ cup to2 cups of liquid or more. Accordingly, the volume of the container mayrange in some instances from 50 to 500 ml, such as 100 to 400 ml,including 200 to 375 ml. Where the container has a pouch or bagconfiguration, the dimensions of such may vary, ranging in someinstances from 2×3 inches to 8×10 inches. While the thickness of thewalls of the container may vary, in some instances the walls have athickness ranging from 0.1 to 2.0 mm, such as 0.1 to 1.0 mm. Thecontainer may be fabricated from any convenient material that isimpermeable to liquid, e.g., an aqueous liquid, where materials ofinterest include polymeric materials (e.g., polyvinylchloride,polyethylene, polyvinylacetate, etc.,) which materials may betransparent, translucent or opaque, as desired.

As summarized above, the container is sealable. Accordingly, thecontainer includes a sealable closure device (e.g., a resealable closuredevice), which when opened provides access to deposit the pharmaceuticalcomposition into the container. The sealable closure device for closingthe container or pouch also provides a closed system for disposing ofthe used medication. The closure system may include an adhesive seal orplastic container reseal device such as those associated with thetrademark ZIPLOC® to seal the pharmaceutical composition in thecontainer.

Present inside of the container is an amount of an inactivatingsubstance. Inactivating substances of interest are those substanceswhich, upon contact with the active agent of the pharmaceuticalcomposition, at least partially inactivate the active agent, i.e., atleast diminish if not destroy the activity of the active agent.Inactivating substances of interest include, but are not limited tobinding agents, where the term “binding agent” means a substance orcombination of substances that immobilize or otherwise deactivate anactive agent on contact. Binding agents of interest include adsorptionsubstances that adsorb the active agent or chemisorb substances thatchemically bind the active agent. Substances of interest are ones whichbegin to perform the immobilization or other deactivation immediately oncontact with the active agent of the pharmaceutical composition.

Binding agents of interest include agents that immobilize the medicationand preclude future separation by normally available means. Specificexamples of such agents include, without limitation, zeolites, clays,silica gel, aluminum oxide and activated carbon. Activated carbon issuitable for the adsorption or chemisorption of active agents, includingsynthetic opioids such as fentanyl. The term “activated carbon” is usedin its conventional sense to refer to a form of carbon that has beenprocessed to provide for a surface area in excess of 500 m². Whenpresent as the binding agent, the activated carbon may be in powder,granular or pelletized form. Powdered activated carbon is a particularcarbon composition having an average particle size of 0.25 mm or less,e.g., from 0.15 to 0.25 mm, while granular or pelletized activatedcarbon is made up of particles or pellets having an average size of 0.25mm or higher, such as from 0.25 to 5.0 mm. In some instances in whichthe activated carbon is present in powder form (as well as other forms),the activated carbon will not be free-flowing in the container, i.e.,the activated carbon will be stably associated with another component ofthe container, e.g., a wall of the container, a solid support in thecontainer, or a pouch inside of the container, such as described ingreater detail below. In yet other instances where the activated carbonis present in granular or pelletized form, the granular or pelletizedform of the activated carbon may be free-flowing in the container.

In addition or alternatively to binding agents, the inactivatingsubstance may include other substances which in some way render theactive agent of the pharmaceutical composition unusable. Accordingly,the inactivating substance may contain one or more of an antagonist, anoxidizing compound, an irritant compound or an anti-abuse distressingagent. Such compounds may be used singly or in combination and insteadof the binding agent or in addition to the binding agent in theinactivating substance. When used in combination with the binding agent,such compounds may be pre-adsorbed on a portion of the binding agent, asdesired. Antagonists of interest are those which exhibit antagonistactivity relative to the active agent of the pharmaceutical composition,e.g., naloxone or naltrexone for opioids. Examples of such oxidizingagents include perborates, percarbonates, peroxides, and hypochlorites.Examples of irritant compounds include capsaicin or ipecac. Examples ofanti-abuse distressing agents include bitter taste agents, such asdehydrocholic acid.

The amount of the inactivating substance in the container may vary, andmay be selected to be more than theoretically required to substantiallyinactivate the amount of active agent in the pharmaceutical compositionfor which the device has been configured. While the exact amount mayvary, in some instances the weight ratio of inactivating substance(e.g., activated carbon) to active agent is 2 (i.e., 2/1) or higher,such as 3 or higher, including 4 or higher, such as 5 or higher.

As indicated above, in some instances the inactivating substance is notfree-flowing inside of the container. In other words, the inactivatingsubstance is stably associated with some other component of thecontainer, e.g., an inside wall of the container, a support present inthe container, a liquid permeable pouch inside of the container, etc. By“stably associated” is meant that the inactivating substance isimmobilized relative to the other component at least prior to use of thecontainer, e.g., prior to inclusion of liquid in the container. As such,in some instances the inactivating substance may be adhered to an innersurface of the container, e.g., as a layer on the inner surface of thecontainer. Where desired, a liquid permeable cover (i.e., liner) may bepositioned over the layer. In other embodiments, a support (e.g., aflexible or rigid, permeable or impermeable, solid structure) may beprovided inside of the container and unattached to the container, wherethe inactivating substance is stably associated with one or moresurfaces of the support.

In some instances, inactivating substance may be present in a liquid,e.g., water, permeable enclosure (such as a pouch), which enclosureallows for liquid to pass into the inside of the enclosure but holds thecontents of the enclosure inside of the enclosure, at least prior tocontact with liquid. In some instances, the enclosure is fabricated froma water permeable material which maintains the inactivating substanceinside of the enclosure after the enclosure has been contacted withliquid. Any convenient material may be employed for the inner enclosure,including materials commonly employed for tea bags, e.g., cellulosematerials, etc. In some instances, the material is one that dissolves inliquid, e.g., water, i.e., the material is water-soluble. In suchembodiments, pouch materials of interest include polymeric materials,e.g., which are formed into a film or sheet. The pouch material can, forexample, be obtained by casting, blow-molding, extrusion or blownextrusion of the polymeric material, for example. Polymers, copolymersor derivatives thereof suitable for use as pouch material include, butare not limited to: polyvinyl alcohols, polyvinyl pyrrolidone,polyalkylene oxides, acrylamide, acrylic acid, cellulose, celluloseethers, cellulose esters, cellulose amides, polyvinyl acetates,polycarboxylic acids and salts, polyaminoacids or peptides, polyamides,polyacrylamide, copolymers of maleic/acrylic acids, polysaccharidesincluding starch and gelatine, natural gums such as xanthum andcarragum; polyacrylates and water-soluble acrylate copolymers,methylcellulose, carboxymethylcellulose sodium, dextrin, ethylcellulose,hydroxyethyl cellulose, hydroxypropyl methylcellulose, maltodextrin,polymethacrylates, polyvinyl alcohols, polyvinyl alcohol copolymers andhydroxypropyl methyl cellulose (HPMC), and combinations thereof. Thepolymer can have any weight average molecular weight, such as from 1000to 1,000,000, e.g., from 10,000 to 300,000 , including from 20,000 to150,000. Mixtures of polymers can also be used as the pouch material.This can be beneficial to control the mechanical and/or dissolutionproperties of the compartments or pouch, depending on the applicationthereof and the required needs. Suitable mixtures include for examplemixtures wherein one polymer has a higher water-solubility than anotherpolymer, and/or one polymer has a higher mechanical strength thananother polymer. Also suitable are mixtures of polymers having differentweight average molecular weights, for example a mixture of PVA or acopolymer thereof of a weight average molecular weight of 10,000-40,000,such as around 20,000, and of PVA or copolymer thereof, with a weightaverage molecular weight of 100,000 to 300,000, such as 150,000. Alsosuitable herein are polymer blend compositions, for example comprisinghydrolytically degradable and water-soluble polymer blends such aspolylactide and polyvinyl alcohol, obtained by mixing polylactide andpolyvinyl alcohol, e.g., comprising about 1-35% by weight polylactideand about 65% to 99% by weight polyvinyl alcohol. The inner enclosuremay or may not be joined to the container.

In some instances, the container further includes one or more excipientswhich impart additional functionality to the container. For example,buffering agents may be included in the container to provide for pHadjustment to a pH which provides for optimal inactivation, e.g., viaadsorption, of the active agent. Any convenient buffering agent thatprovides for the desired pH during use may be employed. Another type ofexcipient of interest is salt, such as a divalent metal cation salt,e.g., where the divalent metal cation is selected from the groupconsisting of Ca²⁺ and Mg²⁺. Such salts may be employed in amountsufficient to prevent the “swelling” (water absorption) of hydrogelpatches when the patch is the pharmaceutical composition. An example ionis the use of calcium or magnesium salts that can be used to minimizethe water absorption and expansion of Lidoderm hydrogel patches. Yetanother excipient of interest is a suspending agent. For example, thecontainer may include an amount of gelling agent which enablessuspension of the activated carbon and medication together in a viscousslurry to achieve intimate contact between the activated carbon anddissolved medication throughout the slurry. One gelling agent that ofinterest is HPMC (Hydroxypropylmethylcellulose), at a concentration byweight of from 0.5 to 5.0% (w/w) when mixed with an amount of water. Theprocess using a gelling agent has an additional advantage because theviscous gel helps retain the mixture, including medications in dissolvedform, within the container, e.g., it will not leak out readily as woulda non-viscous solution should there be a breach in the container. Theabove excipients may be used singly or in combination, and may beprovided in the container separate from the inactivating substance orcombined with the inactivating substance.

Where desired, the container may include a vent. The vent may have anyconfiguration that allows for passage of gas generated during use of thedevice from the inside to the outside of the container. Vents ofinterest include one way gaseous vents which allow for passage of gasfrom inside the container to outside of the container but not viceversa, such as vents typically found in coffee bags, e.g., as describedin U.S. Pat. No. 4,000,846.

Turning now to the Figures, FIG. 1A provides a view of a pharmaceuticalcomposition disposal device 100 according to one embodiment of theinvention. The device 100 includes a container in the form of are-sealable pouch 110 having a ZIPLOC® type seal 120 at the top. Insideof the container 110 is an inner pouch 130 which contains a waterpermeable/granular activated carbon impermeable barrier 140 containingan amount of granular activated carbon 150. Shown in FIG. 1B isvariation of the device shown in FIG. 1A, which includes a one-way gasvent 160 located proximal to the seal 120.

The devices of the invention may be fabricated according to anyconvenient protocol. Such methods generally include placing an amount ofinactivating substance, e.g., granulated or pelletized activated carbon,into a re-sealable container, e.g., as described above. Fabrication mayfurther include placement of other components, e.g., excipients, intothe container, e.g., as described above.

Methods of Use

Aspects of the invention further include methods of disposing apharmaceutical composition by using devices such as described above. Inpracticing methods of the invention, the pharmaceutical composition tobe disposed of is placed inside of the container. A variety of differenttypes of pharmaceutical compositions may be disposed of via embodimentsof the invention, where the pharmaceutical compositions may be liquidsor solids, where solid pharmaceutical compositions may be pills (i.e.,tablets), capsules, topical compositions, such as patches or tapes,among other forms.

Where the pharmaceutical composition is a liquid, the liquidpharmaceutical composition may simply be placed in the container and thecontainer sealed, with no additional liquid introduced into thecontainer. Where the pharmaceutical composition is a solid, a volume ofliquid, e.g., an aqueous medium, such as pure water, may be employed,e.g., to enhance contact of the active agent from the pharmaceuticalcomposition and the inactivating substance. In certain embodiments, theamount of liquid is less than the amount necessary to completelydissolve the pharmaceutical composition. For example, if a drug issoluble at 1 gram per liter, adding less than 1 liter will be ultimatelymore effective for adsorption of the 1 gram of drug. Thus, certainembodiments include addition of water less than the solubility volumefor the medication to be deactivated. When employed, the volume ofliquid may vary, ranging in some instances from ¼ cup to 2 cups. Theprotocol in such instances may vary, with the liquid being introducedinto the container prior to the pharmaceutical composition, or thepharmaceutical composition being introduced into the container prior tothe liquid. After the pharmaceutical composition and liquid have beenintroduced into the container, the container is sealed.

Where desired, the contents of the sealed container may be mixed, e.g.,by agitating the container, manipulating the container if the containeris flexible, etc. However, in some instances, the method does notcomprise any mixing of the contents of the container following sealingof the container. For example, where the pharmaceutical composition is atopical composition such as a patch or tape, methods may include simplyintroducing the composition into the container with an amount of liquidand sealing the container, without subsequent mixing. When thepharmaceutical composition is patch, the patch may be covered with awater permeable layer, e.g., tissue paper, prior to placement into thecontainer, e.g., provide for ease of handling. Where desired, the patchmay be folded, e.g., in half, prior to placement in the container.

After the pharmaceutical composition (and optionally liquid) is placedinside of the container and the container is resealed, the container maybe maintained for a storage period prior to ultimate disposal of thecontainer, e.g., in a municipal sanitation system. When employed, thecontainer may be stored for a period ranging from 1 day to 2 weeks,e.g., 1 to 7 days. During storage, the container may be maintained atany convenient temperature, e.g., room temperature.

FIGS. 2A to 2G provide sequential images of a method of disposing apharmaceutical composition using a device of the invention as depictedin FIG. 1A. In FIG. 2A, a sealed device containing an inner pouch whichin turn includes an amount of granular carbon is shown. During use, thecontainer is opened (see FIG. 2B) and a number of pills are placedinside of the container (FIG. 2C). Next, a volume of water sufficient tocover the pills and the pouch is placed inside of the container (FIG.2D) and the container is resealed (FIG. 2E). FIG. 2F illustratesdissolution of the pills and active agent contained therein in thewater. FIG. 2G illustrates adsorption of the active agent into thegranular activated carbon present inside of the inner pouch.

Utility

The devices of the invention find use in disposal of a variety ofdifferent types of pharmaceutical compositions, e.g., where thepharmaceutical compositions may be liquids or solids, where solidpharmaceutical compositions may be pills (i.e., tablets), capsules,topical compositions, such as patches or tapes, among other forms.Methods and devices of the invention find use is disposing any type ofactive agent, including those that may be subject to abuse, e.g.,opioids and other painkillers, hormones, etc., in a manner that preventsabuse and is environmentally sound (e.g., in that it prevents the activeagent from entering the ecosystem).

Kits

Kits for use in practicing certain methods described herein are alsoprovided.

In certain embodiments, the kits include one or more devices asdescribed above. In certain embodiments, the kits include additionalcomponents that find use in the methods, e.g., an amount of liquid forintroducing into the container, tissue paper, etc., as described above.In a given kit that includes two or more compositions, the compositionsmay be individually packaged or present within a common container.

In certain embodiments, the kits will further include instructions forpracticing the subject methods or means for obtaining the same (e.g., awebsite URL directing the user to a webpage which provides theinstructions), where these instructions may be printed on a substrate,where substrate may be one or more of: a package insert, the packaging,reagent containers and the like. In the subject kits, the one or morecomponents are present in the same or different containers, as may beconvenient or desirable.

Additional Embodiments

1. A device for use in disposing an amount of a pharmaceuticalcomposition, the device comprising:

a sealable container dimensioned to accommodate the pharmaceuticalcomposition; and

an amount of granulated or pelletized activated carbon present inside ofthe of sealable container.

2. The device according to Clause 1, wherein the sealable container is are-sealable container.3. The device according to Clause 1 or 2, wherein the container isconfigured as a pouch.4. The device according to Clause 1, 2 or 3, wherein the granulated orpelletized activated carbon comprises activated carbon particles rangingin size from 0.25 to 5.0 mm.5. The device according to any of the preceding clauses, wherein theamount of granulated or pelletized activated carbon is contained in aliquid permeable enclosure inside of the sealable container.6. The device according to Clause 5, wherein the liquid permeableenclosure is a water permeable enclosure.7. The device according to Clause 5, wherein the device furthercomprises an anti-abuse distressing agent.8. The device according to Clause 7, wherein the anti-abuse distressingagent is combined with the granular activated carbon.9. The device according to Clause 7, wherein the anti-abuse distressingagent is a bitter-tasting agent.10. The device according to any of the preceding clauses, wherein theamount of granulated activated carbon is selected to be more thantheoretically required to substantially inactivate the amount ofpharmaceutical composition for which the device has been configured.11. The device according to any of the preceding clauses, wherein thecontainer further comprises an excipient.12. The device according to Clause 11, wherein the excipient is abuffering agent.13. The device according to Clause 11, wherein the excipient comprises asalt.14. The device according to Clause 13, wherein the salt is a salt of adivalent metal cation.15. The device according to Clause 14, wherein the divalent metal cationis selected from the group consisting of Ca²⁺ and Mg²⁺.16. The device according to any of the preceding clauses, wherein thecontainer comprises a vent.17. The device according to any of the preceding clauses, wherein thecontainer further comprises an amount of a liquid.18. The device according to Clause 17, wherein the liquid is an aqueousliquid.19. The device according to any of the preceding clauses, wherein thedevice comprises a suspending agent.20. A method of disposing an amount of a pharmaceutical composition, themethod comprising:

placing the amount of the pharmaceutical composition into a sealablecontainer comprising an amount of granulated or pelletized activatedcarbon present inside of the of sealable container; and

sealing the sealable container.

21. The method according to Clause 20, wherein the sealable containercomprises an amount of a liquid.22. The method according to Clause 21, wherein the liquid is an aqueousliquid.23. The method according to Clause 21, wherein the method comprisesintroducing the amount of liquid into the sealable container.24. The method according to Clause 21, wherein the amount of liquid isless than the amount necessary to completely dissolve the pharmaceuticalcomposition.25. The method according to any of the preceding clauses, wherein themethod does not comprise any mixing of the contents of the containerfollowing sealing of the container.26. The method according to any of the preceding clauses, wherein thepharmaceutical composition is a liquid.27. The method according to any of the preceding clauses, wherein thepharmaceutical composition is a solid.28. The method according to Clause 27, wherein the pharmaceuticalcomposition is a tablet.29. The method according to Clause 27, wherein the pharmaceuticalcomposition is a capsule.30. The method according to Clause 27, wherein the pharmaceuticalcomposition is a patch.31. The method according to Clause 30, wherein the method comprisesfolding the patch prior to placement of the patch in the sealablecontainer.32. The method according to Clause 30, wherein the method comprisespositioning tissue paper in contact with an adhesive layer of the patchprior to placement of the patch in the sealable container.33. The method according to any of the preceding clauses, wherein themethod comprises maintaining the sealed container for an incubationperiod prior to disposing the container.34. The method according to Clause 33, wherein the incubation periodranges from 1 to 7 days.35. The method according to Clause 33, wherein the method comprisesdisposing the container in a municipal sanitation system.36. A kit comprising:

a sealable container; and

an amount of granulated or pelletized activated carbon.

37. The kit according to Clause 36, wherein the amount of granulated orpelletized activated carbon is present inside of the sealable container.38. The kit according to Clause 36 or 37, wherein the amount orgranulated pelletized activated carbon is contained in a liquidpermeable enclosure inside of the sealable container.39. The kit according to Clause 36, 37 or 38, wherein the kit furthercomprises an amount of liquid.40. The kit according to any of the preceding clauses, wherein the kitfurther comprises tissue paper.41. A method comprising placing an amount of granulated or pelletizedactivated carbon into a re-sealable container.42. The method according to Clause 41, wherein the amount granulated orpelletized activated carbon is contained in a liquid permeableenclosure.43. The method according to Clause 41 or 42, wherein the method furthercomprises placing an amount of an anti-abuse distressing agent into there-sealable container.44. The method according to Clause 41, 42 or 43, wherein the methodfurther comprises placing an amount of an excipient into the re-sealablecontainer.45. The method according to Clause 44, wherein the excipient is selectedfrom the group consisting of buffering agents, salts of divalent cationsand combinations thereof.46. A device for use in disposing an amount of a pharmaceuticalcomposition, the device comprising:

a sealable container dimensioned to accommodate the pharmaceuticalcomposition; and

an amount of an inactivating substance present inside of the sealablecontainer, wherein the inactivating substance is not present in afree-flowing form.

47. The device according to Clause 46, wherein the inactivatingsubstance is activated carbon.48. The device according to Clause 47, wherein the activated carbon ispresent in powdered, granulated or pelletized form.49. The device according to any of the preceding clauses, wherein theamount of inactivating substance is present in a liquid permeable pouchor the amount of inactivating substance is adhered to at least a portionof the inner surface of the container or the amount of inactivatingsubstance is secured to a portion of the inner surface of the containerby a liquid permeable liner or the amount of inactivating substance isadhered to a surface of a solid support.50. The device according to any of the preceding clauses, wherein thedevice further comprises an anti-abuse distressing agent.51. The device according to Clause 50, wherein the anti-abusedistressing agent is combined with the granular activated carbon.52. The device according to Clause 50, wherein the anti-abusedistressing agent is a bitter-tasting agent.

The following examples are offered by way of illustration and not by wayof limitation. Specifically, the following examples are of specificembodiments for carrying out the present invention. The examples are forillustrative purposes only, and are not intended to limit the scope ofthe present invention in any way.

EXAMPLES I. Test of the General Medication Deactivation System, using A)Granular Activated Carbon in Direct Contact With the Solution, and B)Granular Activated Carbon Self Contained in a Water Permeable InnerPouch A. Procedure:

Using 4 mg Dexamethasone pills as a model drug, 30 pills are placed intoeach of five pouches containing: 1) no absorbent (Control); 2) 45 gramsof Generic Cat Litter; 3) 45 grams of Used Coffee Grounds; 4) MedsAway™Design “A”: 45 grams of freely accessible granular activated carbon(analogous to the device shown in FIG. 1A without the inner pouch butwith free granular activated carbon); and 5) MedsAway™ Design “B”: 45Grams of Granular Activated Carbon contained in an inner waterpermeable/carbon impermeable pouch (analogous to FIG. 1A). 1 cup of tapwater is added to each pouch followed by a 7-day incubation period. Thedrug contained in the water solution is analyzed. In a final wash-outtest, the contents of each pouch is diluted in 1 gallon tap water, mixedperiodically for 1 day, and the water-released dexamethasone is analyzedby HPLC.

B. Results:

The results of the experiment are presented graphically in FIG. 3. Nomeasureable dexamethasone was released into either MedsAway Design “A”or

MedsAway Design “B”. A significant amount of dexamethasone was releasedin all other conditions.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

1-55. (canceled)
 56. A device comprising: a sealable containerdimensioned to accommodate a pharmaceutical composition; an amount ofactivated carbon present inside of the of sealable container; and apharmaceutical composition present inside of the sealable container. 57.The device according to claim 56, wherein the sealable container is are-sealable container.
 58. The device according to claim 56, wherein thecontainer is configured as a pouch.
 59. The device according to claim56, wherein the activated carbon comprises granulated or pelletizedactivated carbon.
 60. The device according to claim 59, wherein thegranulated or pelletized activated carbon comprises activated carbonparticles ranging in size from 0.25 to 5.0 mm.
 61. The device accordingto claim 56, wherein the amount of granulated or pelletized activatedcarbon is contained in a liquid permeable enclosure inside of thesealable container.
 62. The device according to claim 56, wherein theliquid permeable enclosure is a water permeable enclosure.
 63. Thedevice according to claim 56, wherein the container comprises a vent.64. The device according to claim 56, wherein the container furthercomprises an amount of a liquid.
 65. The device according to claim 64,wherein the liquid is an aqueous liquid.
 66. The device according toclaim 56, wherein the device comprises a suspending agent.
 67. Thedevice according to claim 56, wherein the container is sealed.
 68. Thedevice according to claim 56, wherein the pharmaceutical composition isa solid.
 69. The device according to claim 68, wherein thepharmaceutical composition is selected from the group consisting of apill, tablet, capsule, topical composition and combinations thereof. 70.The device according to claim 56, wherein the pharmaceutical compositionis a liquid.
 71. A device comprising: a sealable container dimensionedto accommodate a pharmaceutical composition; and an amount of aninactivating substance present inside of the sealable container, whereinthe inactivating substance is not present in a free-flowing form; and anamount of a pharmaceutical composition present inside of the sealablecontainer.
 72. The device according to claim 71, wherein theinactivating substance is activated carbon.
 73. The device according toclaim 71, wherein the pharmaceutical composition is a solid.
 74. Thedevice according to claim 73, wherein the pharmaceutical composition isselected from the group consisting of a pill, tablet, capsule, topicalcomposition and combinations thereof.
 75. The device according to claim71, wherein the pharmaceutical composition is a liquid.
 76. The deviceaccording to claim 71, wherein the container is sealed.
 77. A set ofarticles comprising: a sealable container dimensioned to accommodate apharmaceutical composition having an amount of activated carbon presentinside of the of sealable container; and a pharmaceutical composition.78. The set according to claim 77, wherein the sealable container is are-sealable container.
 79. The set according to claim 78, wherein thepharmaceutical composition is a solid.
 80. The set according to claim79, wherein the pharmaceutical composition is selected from the groupconsisting of a pill, tablet, capsule, topical composition andcombinations thereof.
 81. The set according to claim 77, wherein thepharmaceutical composition is a liquid.